MedDataX Logo

GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care

NCT ID: NCT05391126

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-28

Study Completion Date

2027-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (\*1/\*28) (heterozygotes) and usual UGT metabolizers (\*1/\*1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (\*1/\*28, \*1/\*1) will be randomized to genotype-guided dosing versus usual care.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Genocare Guided

Group Type EXPERIMENTAL

Irinotecan

Intervention Type DRUG

Usual dosing per package insert.

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Irinotecan

Usual dosing per package insert.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nano-liposomal Irinotecan Onyvide

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.
* Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed.
* Age ≥ 18 years.
* ECOG performance status ≤ 1.
* Patients must have adequate organ and marrow function as defined below:
* Measurable or non-measurable disease.

Exclusion Criteria

* Patients who received prior treatment with irinotecan are excluded.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
* Pregnant women are excluded from this study.
* Patients who are not planned for treatment of their cancer.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Reema A. Patel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Reema A. Patel

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Reema A Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Reema A Patel, MD

Role: CONTACT

[email protected]
8592186650

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yvonne Taul

Role: primary

[email protected]
859-323-2354

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MCC-22-GI-125-PMC

Identifier Type: -

Identifier Source: org_study_id